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Biosense Webster HELIOSTAR Balloon Ablation Catheter - HSA Registration DE0507573

Access comprehensive regulatory information for Biosense Webster HELIOSTAR Balloon Ablation Catheter in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0507573 and owned by Biosense Webster, Inc.. The device was registered on December 06, 2022.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS D
DE0507573
Biosense Webster HELIOSTAR Balloon Ablation Catheter
HSA Registration Number: DE0507573
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Product Description

The HELIOSTAR Balloon Ablation Catheter is indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) of the atria and, when used with a compatible multi-channel RF generator, for cardiac ablation.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0507573
Registration Date
December 06, 2022
Change Notification Approval Date
September 30, 2024
Retention Due Date
December 05, 2025
Product Owner
Short Name
Biosense Webster, Inc.
Address
31 Technology Drive, Suite 200, Irvine, CA 92618, UNITED STATES
Registrant
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Importer
Address
2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222 2 SCIENCE PARK DRIVE, ASCENT, #07-13, SINGAPORE 118222
Model Information
Model Name(s)
HELIOSTAR Balloon Ablation Catheter
Model Identifier(s)
D138904